Validapro is a consulting firm fully dedicated to the regulatory compliance needs of companies in the life sciences sector, such as the pharmaceutical, biotechnology and medical device industries.
For nearly 25 years, we have been supporting our customers in their compliance projects, from design to inspection. Having assisted our international customers on more than 70 FDA inspections, all successful, we are recognized on the market as an expert, professional and cohesive team.
Our values are contained in the acronym HERE for Human, Expertise, Reactivity & Ethics. If you share these values, are dynamic and looking for an exciting, diversified and rewarding job, we want to meet you.
We are looking to fill one (1) Process Engineer position.
The Process Engineer manages Engineering, Process Optimization and Qualification / Validation projects, including supplier/ service provider management, meeting Canadian, US, European and other regulatory requirements. This position requires international travel (Europe, the US and other countries).
Main tasks and responsibilities
- Manage engineering, process optimization and Qualification / Validation projects within the stipulated timelines and the respect of good practices, including the management of suppliers / service providers;
- Perform gap analysis and definition of Qualification / Validation strategies (e.g. VMP);
- Write specifications, protocols and equipment acceptance reports (e.g. FAT, SAT);
- Write qualification / validation protocols and reports of pharmaceutical production equipment and utilities (IQ, OQ and PQ), execute the protocols in collaboration with the teams in place;
- Write process qualification / validation protocols and reports (manufacturing, cleaning, sterilization) and execute protocols in collaboration with the teams in place;
- Write Quality and Operational documentation (e.g. procedures, production documentation);
- Prepare and deliver training on various topics, both internally (ongoing training of the team) and externally;
- Prepare mass and energy balances, principles diagrams (PFD), process and instrumentation diagrams (P & ID) and other deliverables;
- Prepare feasibility studies;
- Do detailed engineering, start-up support and commissioning
- Bachelor's degree in engineering, member in good standing of the Ordre des ingénieurs du Québec;
- Minimum of five (5) years of experience in the pharmaceutical / biotechnology industry (medical devices an asset);
- Strong knowledge of industrial processes (pharma / biopharma), including technical documents (e.g. electrical / pneumatic diagrams, P & IDs, functional analyzes);
- You have actively led / participated in various Engineering, Process Optimization and Qualification / Validation projects ("Lean / Six Sigma" concepts);
- Experience in Engineering and Qualification / Validation (manufacturing, cleaning, sterilization);
- Knowledge and understanding of international regulatory frameworks (US, Canadian, European, Brazilian) applicable to the pharmaceutical industry (medical devices an asset);
- PMI, Green or Black Belt certification, strengths
- Quality and customer oriented;
- Autonomous, self-motivated, proactive, positive, entrepreneurial spirit;
- Strong interpersonal and communication skills, able to serve a wide range of clients, from small businesses to large multinationals, able to adapt to different cultures and business situations;
- Ability to build effective partnerships with employees, management, departments and multidisciplinary teams to achieve goals;
- Ability to manage multiple projects simultaneously, has a good sense of organization and priority management;
- Excellent writing and communication skills, both oral and written;
- Must be able to work independently and in teams;
- Demonstrates flexibility, ability to adapt quickly to changing priorities or situations;
- Excellent analytical skills for solving problems and systematic approaches to solving them.
- Bilingualism (French and English) both orally and in writing. Spanish or Portuguese an asset
The position is located in Laval (QC). Depending on the case, the mandates will be carried out either from the Laval office, or on customer’s site. Teleworking is also possible. This position requires frequent international travel (Europe, South America or other). Must be willing to travel up to 30% of the time.
Job Type: Full-time
- Bachelor's Degree (Preferred)
- English (Preferred)
- French (Preferred)